Collateral flow channel sealant delivery methods and systems

ABSTRACT

Devices, methods, and systems are provided for occluding a collateral flow channel between a target lung compartment and an adjacent lung compartment. A video-assisted thoracoscopic device is inserted into a thoracic cavity of a patient and positioned at a fissure between a target lung compartment and an adjacent lung compartment. A collateral flow channel between the target lung compartment and the adjacent lung compartment is then identified using the video-assisted thoracoscopic device and an agent is injected into the collateral flow channel, thereby reducing the collateral flow channel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/532,820 (Attorney Docket No. 20920-774.301), filed Aug. 6, 2019,which is a continuation of U.S. patent application Ser. No. 15/182,453(Attorney Docket No. 20920-774.201), filed Jun. 14, 2016, now U.S. Pat.No. 10,413,300, which claims the benefit of U.S. Provisional No.62/183,170 (Attorney Docket No. 20920-774.101), filed Jun. 22, 2015, theentire content of which is incorporated herein by reference in itsentirety.

FIELD OF THE INVENTION

Present disclosure relates generally to devices, methods, and systemsfor delivering an agent to a lung region.

BACKGROUND

Pulmonary diseases, such as chronic obstructive pulmonary disease,(COPD), reduce the ability of one or both lungs to fully expel airduring the exhalation phase of the breathing cycle. Such diseases areaccompanied by chronic or recurrent obstruction to air flow within thelung. Because of the increase in environmental pollutants, cigarettesmoking, and other noxious exposures, the incidence of COPD hasincreased dramatically in the last few decades and now ranks as a majorcause of activity-restricting or bed-confining disability in the UnitedStates. COPD can include such disorders as chronic bronchitis,bronchiectasis, asthma, and emphysema.

It is known that emphysema and other pulmonary diseases reduce theability of one or both lungs to fully expel air during the exhalationphase of the breathing cycle. One of the effects of such diseases isthat the diseased lung tissue is less elastic than healthy lung tissue,which is one factor that prevents full exhalation of air. Duringbreathing, the diseased portion of the lung does not fully recoil due tothe diseased (e.g., emphysematic) lung tissue being less elastic thanhealthy tissue. Consequently, the diseased lung tissue exerts arelatively low driving force, which results in the diseased lungexpelling less air volume than a healthy lung. The reduced air volumeexerts less force on the airway, which allows the airway to close beforeall air has been expelled, another factor that prevents full exhalation.

The problem is further compounded by the diseased, less elastic tissuethat surrounds the very narrow airways that lead to the alveoli, whichare the air sacs where oxygen-carbon dioxide exchange occurs. Thediseased tissue has less tone than healthy tissue and is typicallyunable to maintain the narrow airways open until the end of theexhalation cycle. This traps air in the lungs and exacerbates thealready-inefficient breathing cycle. The trapped air causes the tissueto become hyper-expanded and no longer able to effect efficientoxygen-carbon dioxide exchange.

In addition, hyper-expanded, diseased lung tissue occupies more of thepleural space than healthy lung tissue. In most cases, a portion of thelung is diseased while the remaining part is relatively healthy and,therefore, still able to efficiently carry out oxygen exchange. Bytaking up more of the pleural space, the hyper-expanded lung tissuereduces the amount of space available to accommodate the healthy,functioning lung tissue. As a result, the hyper-expanded lung tissuecauses inefficient breathing due to its own reduced functionality andbecause it adversely affects the functionality of adjacent healthytissue.

Some recent treatments include the use of devices that isolate adiseased region of the lung in order to reduce the volume of thediseased region, such as by collapsing the diseased lung region.According to such treatments, a delivery catheter is used to implant oneor more implantable devices in airways feeding a diseased region of thelung to regulate fluid flow to the diseased lung region in order tofluidly isolate the region of the lung. These implantable devices canbe, for example, one-way valves that allow flow in the exhalationdirection only, occluders or plugs that prevent flow in eitherdirection, or two-way valves that control flow in both directions.

In addition to the above, it is sometimes desirable to provide methodsfor sealing collateral flow channels between adjacent lung segments.Such sealing methods may be particularly useful for treating patientsprior to endobronchial or other lung volume reduction procedures. Thus,methods and apparatus for sealing collateral flow channels should becompatible with known protocols for occluding diseased lung segments andregions for performing lung volume reduction, including the placement ofplugs and occluding members within the airways leading to such diseasedlung segments and regions. One such sealing method and system has beendescribed in U.S. Pat. No. 8,137,302. In other cases, sealing agents maybe provided, though they are not equipped with the systems or methodsfor delivery for collateral channels. Other such sealing agents havebeen used in U.S. Pat. Nos. 7,819,908 and 8,445,589. The objective thusremains to provide additional methods for sealing collateral channels.At least some of these objectives will be met by the inventionsdescribed herein below.

SUMMARY OF THE INVENTION

The present disclosure relates to aspects of methods, and systems foroccluding a collateral flow channel. In one aspect, a method foroccluding a collateral flow channel between a target lung compartmentand an adjacent lung compartment is disclosed. Said method comprisesinserting a video-assisted thoracoscopic device into a thoracic cavityof a patient, positioning the video-assisted thoracoscopic device at afissure between a target lung compartment and an adjacent lungcompartment, identifying a collateral flow channel between the targetlung compartment and the adjacent lung compartment using thevideo-assisted thoracoscopic device, inserting a needle into tissueforming the collateral flow channel, and injecting an agent through theneedle and into the collateral flow channel, thereby reducing thecollateral flow channel. The agent is may be a sealant.

The above method may further comprise placing a clip on the collateralchannel thereby pinching closed the collateral channel. The clip may bea normally closed clip. Alternatively, the method may comprise cuttingtissue at the collateral flow channel thereby disrupting the collateralflow channel.

Additionally, the target lung compartment may be accessed using anendobronchial isolation catheter. The target lung compartment may thenbe isolated using the endobronchial isolation catheter. Pressure and/orflow may be measured within the target lung compartment. Sealing of thecollateral flow channel may then be verified based on the measuredpressure or flow.

The method may further comprise placing an endobronchial valve within anairway leading to the target lung compartment. The endobronchial valvemay be a one-way flow control valve configured to allow air to flow outof the target lung compartment and prevent air flow into the target lungcompartment.

This and other aspects of the present disclosure are described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

Present embodiments have other advantages and features which will bemore readily apparent from the following detailed description and theappended claims, when taken in conjunction with the accompanyingdrawings, in which:

FIG. 1A is a perspective view of one embodiment of an agent deliverycatheter.

FIG. 1B is an axial, cross-sectional view of a distal portion of oneembodiment of an agent delivery catheter comprising a central lumen fordelivery of fluid.

FIG. 2 shows one embodiment of a lung segment assessment system.

FIG. 3 shows a lung segment having a collateral flow channel.

FIG. 4 illustrates one embodiment of a method of delivering an agent.

FIG. 5 shows isolation of a target lung segment.

FIG. 6 shows the delivery of an agent to a collateral flow channel.

FIGS. 7A and 7B show exemplary disruption of collateral flow channels.

DETAILED DESCRIPTION OF THE INVENTION

Although the detailed description contains many specifics, these shouldnot be construed as limiting the scope of the disclosure but merely asillustrating different examples and aspects of the disclosure. It shouldbe appreciated that the scope of the disclosure includes otherembodiments not discussed herein. Various other modifications, changesand variations which will be apparent to those skilled in the art may bemade in the arrangement, operation and details of the method, device,and system of the present embodiments disclosed herein without departingfrom the spirit and scope of the disclosure as described here.

Throughout the specification and claims, the following terms take themeanings explicitly associated herein unless the context clearlydictates otherwise. The meaning of “a”, “an”, and “the” include pluralreferences. The meaning of “in” includes “in” and “on.” Referring to thedrawings, like numbers indicate like parts throughout the views.Additionally, a reference to the singular includes a reference to theplural unless otherwise stated or inconsistent with the disclosureherein.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any implementation described herein as“exemplary” is not necessarily to be construed as advantageous overother implementations.

Throughout this disclosure, reference is made to the term “agent”. Asused herein, the term “agent” refers to a sealing agent. For purposes ofthis application, the term “agent” is interchangeable with “sealant” and“sealing agent.”

Throughout this disclosure, reference is made to the term “lung region”.As used herein, the term “lung region” refers to a defined division orportion of a lung. For exemplary purposes, lung regions are describedherein with reference to human lungs, wherein some exemplary lungregions include lung lobes and lung segments. Thus, the term “lungregion” as used herein can refer, for example, to a lung lobe or a lungsegment. Such nomenclature conforms to nomenclature for portions of thelungs that are known to those skilled in the art. However, it should beappreciated that the term “lung region” does not necessarily refer to alung lobe or a lung segment, but can refer to some other defineddivision or portion of a human or non-human lung.

The present disclosure describes a method for sealing a collateral flowchannel between a target lung compartment and an adjacent lungcompartment. The method comprises navigating a video-assistedthoracoscopic surgical (VATS) device to a fissure between the targetlung compartment and the adjacent lung compartment and identifying acollateral flow channel. Thereafter, an agent, such as a sealant, isinjected into the collateral flow channel, thereby sealing thecollateral flow channel. Additionally, systems comprising theapplication of these methods are also described.

Turning to the figures, FIG. 1A shows a catheter for use in conjunctionwith the present disclosure. Similar delivery catheters have beendescribed in U.S. Pat. Nos. 8,137,302 and 7,883,471, which areincorporated herein by reference. Delivery catheter 110 comprises anelongate catheter body 112 having a proximal end 116, and a distal end114 that comprises an occlusion element 115, which in this case is aninflatable balloon. Catheter body 112 includes at least one centrallumen or passage 118 with a distal opening 119 (shown in greater detailin FIG. 1B). A hub 120 is disposed at the proximal end 116 of thecatheter body 112 and includes at least one port 117 for connection toan inflation lumen 121 which feeds an inflation medium to the expandableelement 115, for sealing the distal end of the catheter within a lungairway. In the embodiment shown in FIG. 1B, catheter 110 comprises acentral lumen or passage 118 for delivery of fluid. The ballooninflation lumen 121 opens through a port 122 to deliver the inflationmedium to the expandable member 115. Although not illustrated, catheter110 may be provided with other features, such as sensors disposed withinor in-line with the catheter. Additionally, the catheter may be providedwith pull wires or other mechanisms for steering the distal ends of thecatheters in order to facilitate advancement through the branchingairways of the lung. Still further additionally, the catheters 110 maybe provided with optical fibers, small CCD's or other cameras, or othermeans at their distal ends for visualizing advancement of the cathetersthrough the airways. The catheter body may be composed of conventionalcatheter materials to provide the desired flexibility andbiocompatibility. Suitable materials include PTFE, PVC, polyurethane,PET, polypropelene or other polymer alloys or interpenetrating networkpolymers (IPNs) with or without metallic and/or ceramic braid orsupport. Using such materials, the catheters may be formed byconventional extrusion techniques.

Further, as shown in FIG. 2 , the catheter 110 terminates at or isin-line with unit 220 that may include components such as a displayunit, a user feedback mechanism and a processor. In this embodiment, thedisplay unit comprises a screen 221 showing input from the one or moresensors within or in-line with the catheter. The user feedback mechanismcomprises a mechanism for user input, such as a touch-screen 221. Otheruser feedback mechanisms may include knobs, dials, buttons, or any othersuch mechanism. The processor (not shown) is internal or otherwiseassociated with unit 220 and is configured to perform functions such asreceive, process, calculate or relay input from the sensor.Additionally, the unit 220 may comprise or may be associated with afluid delivery mechanism (not shown) configured to deliver a fluid(e.g., a gas) via the catheter into the target lung compartment.Further, the processor of the unit is equipped to execute variousfunctions. Such functions may include releasing fluid, releasing anagent, timing the release of the fluid or the agent to a predeterminedevent or user input, measuring input from a sensor, calculating inputfrom a sensor and relaying input or calculations to a display.

The respiratory system of the patient starts at the mouth and extendsthrough the vocal cords and into the trachea where it then joins themain stem bronchi which leads into the lungs, which are comprised ofvarious segments. Each lung segment, also referred to as abronchopulmonary segment, is an anatomically distinct unit orcompartment of the lung which is fed air by a tertiary bronchus andwhich oxygenates blood through a tertiary artery. Normally, the lungsegment and its surrounding fibrous septum (lung walls) are intact unitswhich can be surgically removed or separated from the remainder of thelung without interrupting the function of the surrounding lung segments.

The presence of collateral flow channels in the fibrous septum or wallof a diseased lung segment is problematic since the diseased segmentcannot be removed or even isolated successfully with the collateralchannels intact. In the case of isolation and deflation of the diseasedlung segment, the presence of the collateral channels will permit thereentry of air as the patient breathes. Thus, the methods describedbelow, by occluding the collateral passages, return a lung wall havingcollateral ventilation into a functionally intact lung wall whichpermits subsequent treatment of diseased regions using endobronchial orother treatment protocols.

As seen in FIG. 3 , the individual lobes of a lung each comprise aplurality of lung segments LS which are fed by individual branches ofthe bronchi or airways AW. For example, a first lung segment LS1, asecond lung segment LS2, and a third lung segment LS3 may be fed from asingle airway AW which divides into three branches AW1, AW2, and AW3, asillustrated in FIG. 3 . In the cases of diseased or other compromisedlung segments, however, the fibrous septum may comprise collateral flowchannels CFC therebetween. The collateral flow channels CFC in thefissure FS between the target lung segment LS1 and the adjacent lungsegment LS2 will permit gas flow in either direction prior to thetreatments described herein.

FIGS. 5-7B show the practice of the methods described in FIG. 4 .Optionally, at step 401 the target lung segment LS1 may be assessed todetermine if collateral flow is present. Referring now to FIG. 5 , thecatheter 110 is positioned in the airway AW1 leading into the targetlung segment LS1. By expanding the expandable member 115 in the firstairway AW1, the first lung segment LS1 is isolated, and this isolationis compromised only by any collateral flow channels CFC that allow airto leak in from adjacent lung segments AW2. Thereafter, pressure and/orflow within the target lung segment LS1 is measured. The presence ofcollateral flow is then determined based on the measured pressure and/orflow. Determination of collateral flow is disclosed in U.S. Pat. No.7,883,471 and U.S. Pub. Nos. 2008/0027343, 2003/0051733, 2007/0142742,2012/0149995, all of which are hereby incorporated by reference.

At step 402, one or more incisions are made in the chest of a patient.The incisions may be made at various locations between the ribs. In oneembodiment a separate incision is made for a VATS device 601, aninjection device 602, and a cutting or closing device. In anotherembodiment one or more devices may share a single incision.

A VATS device 601 is inserted, at step 403, through the incision andinto the thoracic cavity of the patient. The VATS device 601 may be athoracoscope comprising a light source and a video camera configured totransmit video to an external monitor.

At step 404, the distal tip of the VATS device 601 is positioned at afissure FS between a target lung compartment and an adjacent lungcompartment. Thereafter, at step 405, a collateral flow channel CFCbetween the target lung compartment and the adjacent lung compartment isidentified using the VATS device 601. In one embodiment, the presence ofcollateral flow is determined in the target lung segment before thecollateral flow channel CFC is identified using the VATS device 601. Inanother embodiment, the collateral flow channel CFC is identified usingthe VATS device 601 without first determining that collateral flow ispresent.

At step 406, a needle 602 is inserted into tissue forming the collateralflow channel CFC. An agent is then injected through the needle 602 intothe collateral flow channel CFC at step 407 thereby reducing or sealingthe collateral flow channel CFC. The agent may take any form such as agel, particles, aerosol, liquid, or autologous blood.

Additionally, at step 408, the collateral flow channel CFC may bedisrupted. In one embodiment, as seen in FIG. 7A, tissue forming thecollateral flow channel CFC is cut, thereby severing the collateral flowchannel CFC. The agent previously injected into the collateral flowchannel CFC will seal the cut therefore preventing the air from enteringor exiting through the incision. The cut may also be sealed usingstaples, sutures, or other surgical methods. In another embodiment, asseen in FIG. 7B, a clip 701 may be placed on the collateral flow channelCFC thereby pinching closed the collateral flow channel CFC. The clip701 may comprise one or more atraumatic portions configured to reducetissue trauma once the contact elements have engaged with tissue. In anembodiment, the clip 701 is a normally closed clip. In otherembodiments, the collateral flow channel CFC may be disrupted usingsutures or staples.

Optionally, at step 409, the target lung compartment may be assessed toconfirm that the collateral flow channel CFC has been sealed and/or toconfirm that no other collateral flow is present. As with step 401, thecatheter 110 is positioned in the airway AW1 leading into the targetlung segment LS1. The expandable member 115 is expanded in airway AW1thereby isolating the target lung segment LS1. Thereafter, pressureand/or flow within the target lung compartment is measured and thepresence or absence of collateral flow is determined based on themeasured pressure and/or flow to confirm that the collateral flowchannel CFC has been sealed and that no other collateral flow ispresent.

At step 410, an endobronchial valve may be placed within the airway AW1leading to the target lung segment LS1. In an embodiment, theendobronchial valve is a one-way flow control valve configured to allowair to flow out of the target lung compartment and prevent air flow intothe target lung compartment, thus causing volume reduction or collapseof the target lung region. Examples of such methods and implants aredescribed, for example, in U.S. patent application Ser. No. 11/682,986and U.S. Pat. No. 7,798,147, the full disclosures of which are herebyincorporated by reference. In addition, a plug may be placed in theairway.

While the above is a complete description of various embodiments, any ofa number of alternatives, modifications, and equivalents may be used inalternative embodiments. Therefore, the above description should not betaken as limiting the scope of the invention as it is defined by theappended claims.

1. (canceled)
 2. A system for occluding a collateral flow channel andtreating emphysema, the system comprising: a video-assistedthoracoscopic surgical device that is configured to be inserted into athoracic cavity of a patient; a closure device that is configured to beinserted into the thoracic cavity of the patient to close a collateralflow channel between a target lung compartment and an adjacent lungcompartment and thereby disrupt the collateral flow channel; and anendobronchial valve that is implantable in an airway leading to thetarget lung compartment to treat emphysema.
 3. The system of claim 2,wherein the closure device comprises a stapling device.
 4. The system ofclaim 2, wherein the closure device comprises a clip.
 5. The system ofclaim 4, wherein the clip comprises one or more atraumatic portionsconfigured to reduce tissue trauma once contact elements of the cliphave engaged tissue at the collateral flow channel.
 6. The system ofclaim 4, wherein the clip is a normally closed clip that is configuredto pinch close the collateral flow channel.
 7. The system of claim 2,wherein the closure device comprises a suture.
 8. The system of claim 2,wherein the closure device is configured to seal the collateral flowchannel.
 9. The system of claim 2, wherein the endobronchial valvecomprises a one-way flow control valve configured to allow air flow outof the target lung compartment and prevent air flow into the target lungcompartment.
 10. The system of claim 2, wherein the video-assistedthoracoscopic surgical device comprises a thoracoscope having a lightsource and a video camera configured to transmit video to an externalmonitor.
 11. The system of claim 10, wherein the video-assistedthoracoscopic surgical device is configured to be positioned at afissure between the target lung compartment and the adjacent lungcompartment, wherein the collateral flow channel between the target lungcompartment and the adjacent lung compartment is identified with thevideo-assisted thoracoscopic surgical device.
 12. The system of claim 2,further comprising an endobronchial catheter having an occlusionelement.
 13. The system of claim 12, wherein the occlusion elementcomprises an expandable balloon configured to isolate the target lungcompartment, wherein flow within the target lung compartment is measuredto determine the presence or absence of collateral flow.
 14. A systemfor occluding a collateral flow channel and treating emphysema, thesystem comprising: a stapling device that is configured to be insertedinto a thoracic cavity of a patient via a video-assisted thoracoscopicsurgical device to close a collateral flow channel between a target lungcompartment and an adjacent lung compartment and thereby disrupt thecollateral flow channel; and an endobronchial valve that is implantablein an airway leading to the target lung compartment to treat emphysema.15. The system of claim 14, wherein the endobronchial valve comprises aone-way flow control valve configured to allow air flow out of thetarget lung compartment and prevent air flow into the target lungcompartment.
 16. The system of claim 14, further comprising anendobronchial catheter having an occlusion element.
 17. The system ofclaim 16, wherein the occlusion element comprises an expandable balloonconfigured to isolate the target lung compartment, wherein flow withinthe target lung compartment is measured to determine the presence orabsence of collateral flow.
 18. The system of claim 17, wherein thestapling device is configured to seal the collateral flow channel.